Trial · Interventional
CompletedPhase 4Registry dataEfficacy of Octreotide Acetate and Cabergoline in Patients With Acromegaly
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 20 participants (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Design
- Allocation not applicable · Open label (no masking)
- Countries
1 country
Germany
- Start
- Mar 2006
- Primary completion
- Jan 2010
- Completion
- Not stated
- First posted
- 14 Sept 2006 (estimated)
- Last update posted
- 6 Mar 2017
- Conditions
- Acromegaly
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 4
Efficacy of Octreotide Acetate and Cabergoline in Patients With Acromegaly
NCT00376064Mar 2006 to Jan 2010 (primary)
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This study will investigate the efficacy of a combination treatment with octreotide acetate and cabergoline in acromegalic patients that are only partially responsive to a somatostatin analog monotherapy
Interventions
- Octreotide acetate and cabergoline/Octrotide and SomavertDrug
Arms1
Experimental
SMS995 + Carbegolin, Somavert + SMS995
Primary outcomes1
Outcomes the sponsor listed as primary.
Biochemical control (% of patients) as measured by GH- and IGF-1-values (baseline, EOS)
Time frame · 8 months
Secondary outcomes(5)
Effect of tumor size
Time frame · 8 months
Biochemical control (mean, normalization) as measured by GH- and/or IGF-1-values
Time frame · 8 months
Control clinical of symptoms of acromegaly
Time frame · 8 months
Quality of Life assessment
Time frame · 8 months
Safety and tolerability as assessed by frequency of AEs
Time frame · 8 months
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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